Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca L.P. NDA 21-153/S-5 9/19/02 9/24/02 10/15/03 Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca L.P. NDA 21-153/S-4 2/27/03 3/10/03 Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca L.P. NDA 21-153 & 21-154 2/20/01 4/23/03 9/7/01 Nexium Indications: N21-153: 1) healing of erosive esophagits; 2) maintenance of healing of erosive esophagitis; and 3) treatment of symptomatic gastroesophageal reflux disease. N21-154: Nexium in combination with clarithromycin and amoxicillin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease or a history of duodenal ulcer disease. Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca L.P. | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, New or Modified Indication | Nexium I.V. (esomeprazole sodium) Injection, AstraZeneca LP, Approval | Nexium (esomeprazole magnesium) Delayed-Release Capsules, Astra Zeneca, Labeling Revision | Nexium I.V. (esomeprazole sodium) Injection, Astra Zeneca, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Patient Population Altered | Nexium (esomeprazole magnesium) Delayed-Release Capsules, Astra Zeneca, Labeling Revision | Nexium IV (esomeprazole sodium) Injection, Astra Zeneca, Labeling Revision | Nexium IV (esomeprazole sodium) for Injection, AstraZeneca, Labeling Revision | Nexium (esomeprazole magnesium) Delayed – Release Capsules, AstraZeneca, Labeling Revision | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, New or Modified Indication | NEXIUM Delayed Release Oral Suspension, AstraZeneca, Approval | Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Labeling Revision | Nexium I.V. (esomeprazole sodium) Injection, AstraZeneca, Labeling Revision | Esomeprazole Magnesium Delayed-Release Capsules, Ranbaxy Labs, Tentative Approval | Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca, Approval ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com